Several activities under the Clinical and Translational Science Institute (CTSI) require prior approval for human subjects and vertebrate animal research. Specifically, most CTSI Pilot Projects and K12 Scholar Projects that involve human subjects or vertebrate animals need formal approval from the National Center for Advancing Translational Sciences (NCATS), the funding source of the CTSA grant. No funds will be released to the award recipient until NCATS has provided this approval.
Prior Approval Requirements
The following items are needed for the NCATS submission 30 days prior to the project start date (if an investigator is not ready to submit to NCATS 30 days prior to the start date, their project timeline will not be altered to accommodate):- Project Information (i.e. submitting investigator, project title)
- IRB Approval
We do not require an initiated IRB application/approval by the Full Application Deadline; however, in order to submit for NCATS approval, certification of IRB approval is required. Therefore, we encourage draft protocols/consent documents be created as far in advance as possible. - Project Abstract
- IRB Approved Protocol
- IRB Approved Consent/Assent/waiver
- Protection of Human Subjects
- Inclusion of Individuals Across the Lifespan
- Inclusion of Women & Minorities
- Recruitment and Retention Plan
- Targeted Enrollment Table
- Biosketches (PI and Key Personnel)
- Documentation of CITI certification
- Data and Safety Monitoring Plan
- IND/IDE Documentation, if applicable
- Budget and Budget Justification
- Project Information (i.e. submitting investigator, project title)
- IACUC Approval
- IACUC Approved Protocol
- NCATS Prior Approval Document Checklist for Live Vertebrate Animals
- Vertebrate Animals Section
Additional documentation will be required if the project is classified as a Clinical Trial and/or Element E.